Are you looking for an opportunity to apply specialized expertise in Patient Reported Outcomes (PRO) /Clinical Outcome Assessments (COA) in oncology drug development?
* GSK is seeking a Director, PRO/COA, ideally with experience in Oncology. In this role, you will ensure that the patient’s voice is included in product development and will have the opportunity to develop novel and innovative endpoints that inform technical success in drug development and facilitate market access.
* You will also be responsible for development of PRO/COA endpoint strategies, and the development and validation of PROs to support registration, reimbursement and differentiation of GSK assets in development
* Master’s or doctoral degree in Psychology, Psychometrics, Social Sciences, Outcomes Research, Health Services Research, Epidemiology or a closely related discipline
* At least 3-5 years of experience in pharmaceutical industry, ideally in oncology drug development
The Patient-Center Outcomes (PCO) team at GSK team is placed within Global Medical Organization in Value Evidence and Outcomes and provides consultancy and scientific expertise to support internal stakeholders in Clinical, Regulatory, Value Evidence and Outcomes and Patient Engagement.
The PCO team also engages with external organizations such as CPATH, NIH, ISOQOL and PCORI, to support GSK’s presence in the fields of patient engagement, measurement science and novel endpoint development to inform treatment benefit.
In this role, you will lead the development of global measurement strategies for trial endpoints such as Patient-Reported Outcomes (PROs) and other COAs for an actively growing Oncology portfolio. As a Director of Oncology PRO/COAs, you should be recognized in the field of outcomes research with experience in the pharmaceutical industry or regulatory environment. The successful candidate may also have experience in contract research organizations or academic settings.
Your role will be varied with responsibilities to establish Patient Centered Outcome (PCO) disease area strategies that support the understanding of humanistic impact of a condition and its treatment on patients and caregivers. In this role you will:
* Be responsible for assessing whether existing instruments are Fit-for-Purpose with attention to content validity and psychometric properties specific to the context of use.
* Make strategic recommendations to address any gaps in evidence, support and develop documentation for PRO/COA regulatory submissions, and develop and support research activities that provide qualitative and quantitative evidence for PRO Dossiers supporting a PRO/COA as fit for purpose.
* Define endpoint strategies, author PRO/COA sections of protocols and analysis plans, and support interactions with regulators with respect to PRO/COA endpoints.
You will be responsible for managing vendors including work development, contract initiation, project milestones, timelines, deliverables, and budgets. You will need to have excellent communication and project management skills that will enable you to act as functional lead in cross-functional teams to identify needs and develop PCO strategies.
Your strong leadership skills will enable you to successfully mentor scientists in the Patient Centered Outcomes and Value Evidence and Outcomes teams.
* Master’s or Doctoral degree Psychology, Psychometrics, Social Sciences, Outcomes Research, Health services research, Epidemiology or a closely related discipline
* Experience with PRO/COA requirements for regulatory and HTA/reimbursement agencies including understanding of the FDA Patient Reported Outcomes Guidance
* Experience with managing PRO development and validation projects
* Communication skills, with stakeholder engagement with Clinical, Health outcomes and Regulatory
Internal Number: WD152865
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.